Detection apparatus for detecting analyte in a liquid sample and method thereof

ABSTRACT

The present invention discloses a detection apparatus, comprising a base layer, wherein the base layer comprises a groove for containing a testing element and a sample chamber for collecting a fluid sample. The detection apparatus can achieve fast, efficient and accurate detection of analytes in liquid samples, make operators to perform testing conveniently and freely, without causing incorrect results. In some preferred modes, the sample chamber comprises a liquid channel.

RELATED APPLICATIONS

This application claims priority to Chinese Application serial no.201710172783.5, filed Mar. 22, 2017 and Chinese Application Serial No.2017114024749, filed Dec. 22, 2017, each of which is incorporated hereinby reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to an apparatus for detecting analyte in aliquid sample and method thereof.

BACKGROUND

The following background art is provided to assist readers inunderstanding the present invention rather than a prior art.

At present, illegal drug abuse has become a recognized and increasinglyworsening social problem. In 2003, the survey conducted by the USDepartment of Health and Human Services revealed that about 19.5 millionAmericans or 8.2% of people over the age of 12 are taking illegal drugs.“Recent use of illegal drugs” refers to the use of an illegal drugwithin one month before the US Department of Health and Human Servicesconducted a survey. Cannabis is found to be the most commonly usedillegal drugs, accounting for 6.2% (14.6 million). Now about 2.30million people (1.0%) are using cocaine, 604,000 people use Crack, and 1million people are using hallucinogens, and it is estimated that 119,000people are using heroin.

In order to fight against the drug abuse monitor this social problem,the drug testing has become a standard test procedure in variousindustries such as hiring, education, sports, and law enforcement, etc.To promote this effort, the drug testing industry has formed. Thisindustry has provided a wide range of drug testing products. The urinesample collection cup for sample analysis is a classic testing product.These devices may be complex, difficult or dirty for users, or may causethe problem of adulteration in the sample to conceal the use of illegaldrugs recently. In addition the urine samples cannot be collected insome cases, for example, on the roadside or in the public places.

Many other sample collection and testing devices are inefficient inextracting samples from the collection device, with many problems, suchas environmental contamination caused by leakage of samples, or the testresults are affected by less or more samples collected, or the detectionis complicated with a number of operating steps. Many of these devicesare very complex in the design and manufacturing, requiring expensivematerials. Therefore, it is necessary to collect and test samples withbetter method and apparatus.

SUMMARY

In order to solve the problems existing in the prior art, the presentinvention provides a detection apparatus for detecting analyte in afluid sample and a detection method thereof. With this apparatus anddetection method, a number of problems can be avoided, so as to providean operating method with superior performance and more reliable testresults.

An object of the present invention is to provide a detection apparatus,comprising a base layer that supports testing element, wherein the baselayer comprises a groove for containing a testing element and a samplechamber for collecting a fluid sample.

In some preferred modes, a testing element is provided in the groove andpart of a sample applying area of the testing element is located in asample chamber.

In some preferred modes, the apparatus further comprises a coveringlayer covering the groove on the base layer to form a partially sealedchannel that can be used to accommodate the testing element; optionally,the covering layer covers the groove to seal. Optionally, the channelincludes a testing element.

In some preferred modes, part of the sealed channels form a samplechamber to collect fluid samples. In some preferred modes, the samplechamber comprises an opening that is located at the groove, optionally,part of the groove is not sealed to form the opening, and the openingforms the sample chamber opening.

In some preferred modes, the base layer is a flat structure, on which anumber of grooves that accommodate testing elements are provided.

In some preferred modes, the base layer is a rigid base layer and thecovering layer is a flexible covering layer. Optionally the base layerhas a certain thickness and the thickness of the covering layer is lessthan that of the base layer.

In some preferred modes, the base layer is transparent, the coveringlayer is opaque, and the opening is located on a transparent base layer;optionally, the base layer is opaque and the covering layer istransparent, and the opening is located on the covering layer; or, inboth of the above means, a corresponding opening is formed on both thebase layer and the covering layer as the opening of the sample chamber.

In some preferred modes, the testing element comprises a testing areaand a sample applying area, wherein the testing area is at thedownstream of the sample applying area.

In some preferred modes, the base layer is covered with a flexiblecovering layer, which makes the card slot to form a partially sealedchannel. In some preferred modes, the opening is located on the baselayer and this opening is used to allow the fluid sample to flow intothe sample chamber. In some preferred modes, the opening is located onthe covering layer and is used to allow the fluid sample to flow intothe sample chamber. The fluid sample entering the sample chamber comesinto contact with a portion of the sample applying area on the testingelement, thereby allowing the fluid sample to flow from the testing areato the testing area, thereby completing the detection of analyte in thesample. In some preferred modes, a portion of the sample applying areaof the testing element is located in the sample chamber. In somepreferred modes, the seal is liquid seal or gas seal.

In some preferred modes, in a card slot that contains a testing element,the remaining portion of the card slot other than the opening for thefluid sample to flow into the sample chamber are covered by a coveringlayer and sealed to form a channel.

In some preferred modes, the base layer rigid structure is made byone-time molding, in particular, by one-time injection molding. Thecovering layer is a flexible or rigid material that can be covered onthe base layer to seal the card slot so as to form an opening at one endand a sealed channel at one end, and a portion of the test strip islocated in the channel. Preferably, the labeled area of the test stripand the detecting area are located in the sealed channel, wherein theopening is on a rigid base layer. In some preferred modes, the openingis located on the base layer that forms the card slot and corresponds toa portion of the sample applying area.

In some preferred modes, a structure that reduces, limits or eliminatescapillary flow is located on the card slot, in particular, on the bottomsurface of the card slot or the side wall of the card slot, so thatliquid can flow on the testing element to the greatest extent, ratherthan flow along the gap formed between the test strip and the card slot.The so-called gap is the capillary gap. Said “reduces” is to allow partof the liquid not to flow through the capillary gap, said “limits” is toallow the liquid to flow through the capillary gap to the minimum, andsaid “eliminates” is to make no liquid to flow through the capillarygap, for example, 100% stop, 5% Stop, 90% stop, 89% stop.

In some preferred modes, a protruding tenon structure is included on theside wall of the card slot to prevent part of the liquid from flowingalong the capillary gap formed by the test strip and the sidewall. Forexample, structures on the bottom or side wall of the card slot forreducing, limiting or eliminating capillary flow, e.g. these tenonstructures can block capillary flow, and in addition, they make the gapbetween the test strip and the side wall of the card slot to be largerthan the size of capillary flow, thereby eliminating the capillary flowof liquid through the test strip and the side wall of the card slot intothe sealed card slot channel, producing a “flooding” phenomenon.

In some preferred modes, a structure that reduces capillary flow islocated at the upstream of a labeled area of a testing element, or atthe downstream of the testing area, or at the upstream of a samplechamber; preferably, a structure that reduces capillary flow is locatedat the upstream of a labeled area of a testing element, or a structurethat reduces capillary flow is set corresponding to a labeled are of atesting element. In some preferred modes, the capillary flow is thecapillary space formed between a test strip and a card slot, or thecapillary gap formed between a test strip and the bottom of a card slot.

Of course, these tenon structures serve to fix the test strip.

In some preferred modes, the card slot comprises a pressure reliefstructure, or an exhaust structure, when liquid enters a sealed cardslot channel by the capillary flow of test strip, the pressure in thesealed card slot channel increases. If the pressure is not released viaa structure in the channel, then the capillary flow cannot continue, andthe test strip does not work, forming a “non-working” phenomenon. Insome preferred modes, the structure for pressure relief or exhaust is agroove structure. In a preferred mode, the groove forms a “↑” or anarrow shape. Preferably, the direction of the arrow top is consistentwith the flow direction of sample on the testing element. In somepreferred modes, the groove structure for pressure relief or exhaust islocated at the upstream of the labeled area of the testing element, orat the downstream of the testing area or the upstream of the samplechamber; preferably, the groove structure for pressure relief or exhaustis located at the upstream of the labeled area of the testing element,or the groove structure for pressure relief or exhaust is arrangedcorresponding to the labeled area of the testing element. In somepreferred modes, the structure for pressure relief or exhaust is locatedat the bottom of the card slot, wherein one end of the structure iscommunicated with the interior of the card slot and the other end iscommunicated with the outside, to facilitate the gas removal. In somepreferred modes, one end of the groove structure is communicated withthe interior of the card slot and the other end is communicated with theoutside (for example, via an opening), to facilitate the gas removal. Insome preferred modes, the structure for pressure relief or exhaust islocated at the bottom of the card slot, wherein one end of the structureis communicated with the interior of the card slot and the other end iscommunicated with the opening, thereby facilitating the gas removal.

In some preferred modes, the sample chamber comprises a supportingstructure that supports a sample applying area of a testing element sothat all areas of a test strip are in a plane. In some preferred modes,the supporting structure for supporting the sample applying area islocated in the sample chamber. In some preferred modes, the samplechamber is formed by or consists of a bottom, a portion of the coveringlayer and a portion of the base layer. Optionally, the sample chambercomprises a bottom, an opening, a portion of a covering layer, and aportion of a groove. In some preferred modes, the sample chamber hasrecessed side walls.

In some preferred modes, a testing element is provided in the groove andpart of a sample applying area of the testing element is located in asample chamber. Preferably, the apparatus further comprises a coveringlayer covering the groove on the base layer to form a partially sealedfirst sealed channel and a second sealed channel, the first and thesecond sealed channels accommodate part of the testing element and thesecond sealed channel forms the sample chamber. Preferably, the baselayer comprises a back side and a front side, the groove is located onthe back side or front side of the base layer, and the covering elementcovers the front side or back side of the base layer. Preferably, thedetection apparatus further comprises an opening that is communicatedwith the sample chamber, to allow liquid to enter the sample chamberfrom the opening.

In some other preferred modes, the sample chamber comprises one or moreliquid channels. The liquid channels are communicated with the sampleapplying area of the test strip. Preferably, the liquid channel isdisposed at the upstream of an opening. Preferably, the liquid channelis disposed on a collection chamber. Preferably, the liquid channel isdisposed at the bottom of a collection chamber. Preferably, the liquidchannel exposes a portion of the test strip. Preferably, the liquidchannel exposes an end portion of a test strip. Preferably, the size ofthe liquid channel makes the liquid sample stored in the sample chamberunable to flow out of the sample chamber through the liquid channel dueto the surface tension. Preferably, the size of the liquid channel isset such that the liquid sample in the sample chamber will flow out ofthe sample chamber via the liquid channel that is not occupied by thetest strip due to surface tension when test strip occupies a portion ofthe channel.

The present invention provides a method of detecting analyte in a liquidsample, the method comprising: providing a device as in any of thepreceding embodiments, soaking one end of a sample chamber into theliquid sample and keeping for a period of time, then taking out andreading the test results on the testing element.

Alternatively, the present invention provides a method of detecting ananalyte in a liquid sample, comprising: providing the apparatus as inany of the preceding embodiments, soaking the entire detection apparatusin a liquid sample and keeping for a period of time, then taking out andreading the result on the testing element.

In some preferred modes, “keeping for a period of time” can be 1 secondto 1 hour. Preferably, keep for 1 second, 3 seconds, 5 seconds, 20seconds, 30 seconds, 40 seconds, 50 seconds, 1 minute, 2 minutes, 3minutes, 5 minutes, 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1hour.

In some preferred modes, the soaking is partially or entirely soaking.In some modes, including throwing, inserting or soaking the detectionapparatus into the liquid sample in a random or free way for any periodof time. Here, “any period of time” can be 1 second to 1 hour, e.g. 1second, 3 seconds, 5 seconds, 20 seconds, 30 seconds, 40 seconds, 50seconds, 1 minute, 2 minutes, 3 minutes, 5 minutes, 10 minutes, 20minutes, 30 minutes, 45 minutes, 1 hour.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C are a schematic structural diagram of a detection apparatusaccording to the present invention, in which FIG. 1A is a schematicdiagram of a card slot on a base layer, in which the left one is aschematic diagram of a combined detection apparatus, and the middle oneis a structure diagram of a base layer containing a card slot, and theright one is a structure diagram of a covering layer. FIG. 1B is aschematic structural diagram of a testing element in a specificembodiment. FIG. 1C is a schematic structural diagram of a top view of atesting element placed in a card slot.

FIG. 2 is a three-dimensional structural diagram of a testing elementaccording to an embodiment of the present invention.

FIG. 3 is a schematic structural view (back surface) of a base layeraccording to an embodiment of the present invention.

FIG. 4 is an enlarged three-dimensional structure diagram of a part ofthe base layer in FIG. 3.

FIG. 5 is an enlarged schematic view of a partial structure of a cardslot of a base layer structure according to an embodiment.

FIG. 6 is an enlarged partial schematic diagram of a card slot of a baselayer structure (physical product) according to an embodiment (samplechamber position).

FIG. 7 is a three-dimensional structural diagram of a base layer aftercovering the back side (the covering layer is the back side).

FIG. 8 is a cross-sectional structural diagram of a covering layer aftercovering the back of a base layer according to an embodiment of thepresent invention.

FIG. 9 is a physical structural view of the front of a base layer.

FIG. 10 is a three-dimensional structural view of a testing elementplaced on a base layer.

FIGS. 11A-C are a schematic diagram of an isolated structure of a coveraccording to an embodiment of the present invention. FIG. 11A is athree-dimensional structural view of a cover body; FIG. 11B is aschematic diagram of an internal structure. FIG. 11C is across-sectional structure diagram of a cover body.

FIG. 12 is a three-dimensional structural view of a base layer accordingto an embodiment of the present invention (with a card slot, without atest strip).

FIG. 13 is a front view of a base layer shown in FIG. 12.

FIG. 14 is a three-dimensional structural view of a base layer as shownin FIG. 12, with a test strip provide in the card slot and a coveringlayer covering the test strip.

FIG. 15 is a schematic front view of a base layer of the detectionapparatus shown in FIG. 14 (testing in the card slot).

FIG. 16 is a schematic view of the use of the detection apparatus asshown in FIG. 15.

DETAILED DESCRIPTION

The structures involved in this invention or the used technical termsare further described below. These descriptions are only to explain howto achieve the ways in this invention through examples, and will notrestrict this invention.

Detection

Detection means to assay or test the presence or absence of a substanceor material, including but not limited to chemical substances, organiccompounds, inorganic compounds, metabolic products, medicines or drugmetabolites, organic tissues or metabolites of organic tissues, nucleicacids, proteins or polymers. Additionally, detection means to test thequantity of a substance or material. Furthermore, assay also meansimmunodetection, chemical detection, enzyme detection, and etc.

Downstream and Upstream

Downstream and upstream are divided according to the flow direction ofliquid, and generally, liquid flows from upstream to downstream regions.The downstream region receives liquid from the upstream region, andalso, liquid can flow to the downstream region along the upstreamregion. Here we often divide the regions according to the flow directionof liquid. For example, on some materials that use capillary force topromote liquid to flow, liquid can flow against the gravity direction,at this time, the upstream and downstream regions are still dividedaccording to the flow direction of liquid.

Gas Flow or Liquid Flow

Gas flow or liquid flow means that liquid or gas can flow from one placeto another place. The flow process may pass through some physicalstructures, to play a guiding role. The “passing through some physicalstructures” here means that passing through the surface of thesephysical structures or their internal space and flow to another placepassively or actively, where passivity is usually caused by externalforces, such as the flow of the capillary action. The flow here may meanflow of gas or liquid due to self action (gravity or pressure), orpassive flow.

Testing Element

Various testing elements can be combined and applied to this invention.The testing element comprises a test strip, which can be analyzed invarious forms such as immunoassay or chemical test to detect suchanalyte in samples as drugs or relevant metabolites indicating physicalconditions. In some forms, the test strip is a water absorbent materialhaving liquid sample adding (applying) area, reagent area and testingresult area. Samples are added to the adding area, and flow to thereagent area under the capillary action. In the reagent area, samplesdissolve the reagent and mix with it to detect analyte (if there isanalyte in samples). Certainly, the reagent area and the sample addingarea can also be the same one area. Some reagents treating liquidsamples are disposed in advance in the adding area. And samples withreagents continue to flow to the testing result area. Other reagents arefixed in the testing result area, and these reagents react and combinewith analyte (if there is analyte in samples) or the first type ofreagent in the reagent area. In the noncompetitive detection form, ifthere is analyte in samples, signals will be generated; and if not,signals will not be generated. In the competitive detection form, ifthere is no analyte in samples, signals will be generated; and if not,signals will not be generated. The invention applies to the testingelement of various analytic forms.

When the testing element is a test strip, as shown in FIG. 1C and FIG.2, it can be made from water absorbent or non-water absorbent materials.A test strip can use various materials to transmit liquid, and onematerial can be superposed on another material. For example, a filterpaper can be superposed on the nitrocellulose. Or in the test strip, aregion that at least contains one material is located behind the otherregion that at least contains a different material. In such case, theliquid circulates among regions, and they can be superposed on oneanother or choose not to superpose.

Materials on the test strip can be fixed on, for example, the holder 27of a plastic liner or hard surface, to enhance the test strip'ssustainable power. The test strip, consisting of a water-absorbingmaterial, can flow on the test strip due to capillary action. Thematerials in different areas can be the same or different, and liquidflow is maintained between these areas composed of same or differentmaterials, by this way, the sample solution can flow along the teststrip.

In some embodiments where some detected objects are detected through asignal generation system (for example, at least one enzyme reactsspecifically with the detected object), at least one substancegenerating signals can be absorbed on the analyte detecting area of thetest strip, just like being absorbed specifically on the materials ofthe test strip as described above. In addition, substances generatingsignals in the sample adding area, reagent area and analyte detectingarea of the test strip or all over the whole test strip can bepretreated in advance on one or more materials of the test strip, whichcan be achieved by adding the solution of substances generating signalsto the surface of the application area or soaking one or more materialsof the test strip in the signal solution, after which dry the teststrip. Moreover, the above method can be used to pretreat substancesgenerating signals in the sample adding area, reagent area and analytedetecting area of the test strip or all over the whole test strip inadvance on one or more materials of the test strip. Furthermore, thesignal substance existing in the sample adding area, reagent area anddetecting area of the test strip can be added to one or more surfaces ofthe test strip materials as the labeling reagent.

Areas of the test strip 20 can be arranged as follows: a complete andnecessary test strip can comprise a sample applying area 23 and atesting area 22. Generally, liquid first contacts the sample addingarea, and then flows to the testing area 22 under the capillary action.Certainly, the test strip can also comprise the following areasaccording to the needs: a sample adding area or applying area 23, or atleast a reagent area, and a testing area 22 which comprises a testresult area 24, or at least a control area 25, or at least anadulteration detecting area and a liquid absorption area 21. If thedetecting area comprises a control area, the preferred control area islocated behind the analyte detecting area of the testing result area.All these areas or their combinations can be on a single test stripcontaining a material. Additionally, these areas are made from differentmaterials, and are connected together according to the transmissiondirection of liquid. For example, liquid can be transmitted directly orindirectly among different areas. In this embodiment, different areascan be connected end to end or superposed mutually along the directionof liquid transmission, or connected through other materials such asconnecting medium materials (water absorbent materials such as filterpaper, glass fiber or nitrocellulose are preferred). By use of theconnecting materials, the liquid can flow on materials that connect eacharea end to end, materials that connect each area end to end but theliquid does not flow, or materials that each area is overlapped mutually(including but not limited to overlapping from end to end) but theliquid does not flow.

If the test strip contains an adulteration detecting control area, thearea can be arranged before or after the result detecting area. When theresult detecting area contains a control area, the adulteration controlarea is preferred to be arranged before the control area. In oneembodiment of this invention, the test strip is used for analyticaljudgment and/or control of adulteration. The adulteration control areacan be arranged before or after the control area, and preferably, beforethe control area.

In the specific embodiment of this invention, any forms of testingelements or test strips can be located in a card slot or slot 100 ofbase layer 104, 30, or in the channel formed by covering the card sloton the base layer by the covering element. The channel formed isintended to accommodate only test strip and is not intended to be usedor involved with the transmission of fluid samples. So, the fluidsamples to be tested are expected to flow on the test strip by virtue ofthe test strip's own capillary action. However, considering the cost andtesting of different analytes, usually a test strip is placed in each ofmultiple card slots. For example, 10 test strips can be used to test 10different analytes. The card slots formed will affect the test resultson the test strip because the card slot has physical contact with theanalyte. This kind of physical contact will affect the performance ofthe liquid on the test strip, thereby affecting the test accuracy andeffectiveness. Detailed descriptions on how to arrange the test strip inthe detection apparatus and how to effectively avoid the above technicalproblems will be given below in the invention.

Samples

The detection apparatus provided in the invention can be used to detectsamples including biological liquid (such as case liquid or clinicalsamples). The liquid sample or fluid sample can come from solid orsemi-solid samples, including excreta, biological tissues and foodsamples, and these solid or semi-solid samples can be converted toliquid samples by using any suitable methods such as mixing, crushing,macerating, incubating, dissolving or digesting the solid samples in asuitable solution (such as water, phosphate solution or other buffersolutions) with the enzymolysis. “Biological samples” comprise samplesfrom animals, plants and food, such as urine, saliva, blood and itscomponents, spinal fluids, vaginal secretion, sperms, excrement, sweat,secreta, tissues, organs, tumors, cultures of tissues and organs, cellcultures and media from human or animals. The preferred biologicalsample is urine; food samples comprise food processed substances, finalproducts, meat, cheese, liquor, milk and drinking water; and plantsamples comprise samples from any plants, plant tissues, plant cellcultures and media. “Environmental samples” come from the environment(such as liquid samples coming from lake or other water bodies, sewagesamples, soil samples, underground water, sea water and effluentsamples), and can also comprise waste water or other sewage water.

Any analyte can be detected by using this invention and a suitabletesting element. Preferably, this invention is used to detect the drugmicromolecules in saliva and urine.

Analyte

Examples that can use the analyte related to this invention include somehapten substances, including drugs (such as drug abuse). “Drug abuse”(DOA) means to use drugs (often to paralyze the nerves) for non-medicalpurposes, which will lead to physical and mental damages, and people whouse drugs will be dependent on, addicted to drugs and/or die. Examplesof drug abuse include abuse of cocaine, amphetamine AMP (e.g. BlackBeauty, white amphetamine tablets, dextroamphetamine, dextroamphetaminetablets, Beans); methylamphetamine MET (crank, meth, crystal, speed);barbiturate BAR (such as Valium, Roche Pharmaceuticals, Nutley, N.J.);sedatives (i.e. sleeping adjuvants); lysergic acid diethylamide (LSD);inhibitors (downers, goofballs, barbs, blue devils, yellow jackets,methaqualone); tricyclic antidepressants (TCA, i.e. imipramine,amitriptyline and doxepin); methylene dioxymetham-phetamine MDMA;phencyclidine (PCP);

tetrahydrocannabinol (THC, pot, dope, hash, weed and etc.); opiates(i.e. morphine MOP or opium, cocaine COC, heroin, OXY); antianxietydrugs and sedative hypnotics, the antianxiety drugs are drugs mainlyused to relieve anxiety, tension, fear and stabilize emotions, havingthe function of hypnosis and sedation, including BZO (benzodiazepines),atypical BZ, fused dinitrogen NB23C, benzodiazepines, ligand of BZreceptors, open-loop BZ, diphenylmethane derivatives, piperazinecarboxylate, piperidine carboxylate, quinazolinones, thiazines andthiazole derivatives, other heterocyclic, imidazolesedatives/painkillers (such as OXY, MTD), propanediolderivatives-carbamates, aliphatic compounds, anthracene derivatives andetc. The detection apparatus provided in this invention can also be usedto detect medicines that are easy to overdose for the medical purpose,such as tricyclic antidepressants (imipramine or analogues) andacetaminophen. These medicines will be resolved into differentmicromolecular substances after being absorbed by human body, and thesemicromolecular substances will exist in blood, urine, saliva, sweat andother body fluids or in some of the body fluids.

For example, the analyte detected by this invention includes but notlimited to creatinine, bilirubin, nitrite, (non-specific) proteins,hormones (such as human chorionic gonadotropin, progesterone hormone,follicle-stimulating hormone), blood, leucocytes, sugar, heavy metals ortoxins, bacterial substances (such as proteins or sugar substancesagainst specific bacteria, such as Escherichia coli 0157:H7,Staphylococcus, Salmonella, Fusobacterium, Xampylobacter, L.monocytogenes, Vibrio or Bacillus cereus) and substances relevant withthe physiological features in the urine sample, such as pH and specificgravity. For any other clinical urine chemical analysis, the detectioncan be made by combining the lateral cross flow detection form and theapparatus provided in this invention.

Detection Apparatus

The detection apparatus provided in the present invention can be used todetect the presence or absence of, or the quantity of an analyte in asample (for example, fluid sample) by using any technical principle,that is, the qualitative and quantitative detection. The detectionapparatus comprises a testing element detecting the presence or absenceof, or the quantity of the analyte in the sample, and also a device thataccommodates the testing element.

The detection apparatus of the present invention comprises a base layer,and the base layer comprises a groove for accommodating a testingelement and a covering element used for covering and sealing the groove.By this way, the covering element can cover or seal the testing elementin the groove, to carry out testing of samples. Preferably, thedetection apparatus further comprises a sample chamber, in which part ofthe sample applying area of the testing element is located in the samplechamber. Preferably, the sample chamber consists of a partial groove anda covering layer. In some preferred modes, the base layer has an openingthat allows the liquid sample to enter the sample chamber. In somepreferred modes, the covering layer has an opening that allows theliquid sample to enter the sample chamber.

The detection apparatus of the present invention can also be combinedwith other devices to complete the detection of analyte in a sample.Such devices may be a detection result reading device, a scanning devicefor reading the detection results, storing the result data ortransmitting the data, etc. Of course, the detection apparatus of thepresent invention may also be disposed in some containers, such as acup, which includes a plurality of chambers for collecting the fluidsamples. The detection apparatus of the present invention is disposed ina chamber of a cup. Once the cup collects a fluid sample, the fluidsample will contact the test strip on the detection apparatus, tocomplete the assay.

Base Layer, Covering Element, Testing Element

The detection apparatus of the present invention comprises a base layer,and the base layer comprises one or more card slots. For example, themiddle diagram in FIG. 1A in FIG. 1 shows a detection apparatus withcard slot(s). The base layer 104 comprises a card slot 100. The baselayer 104 has a certain thickness, and a slot (also known as card slot,channel of opening) with a certain depth can be opened in the baselayer. The width of the card slot 100 is equivalent to the width foraccommodating the testing element, or greater than the width of teststrip, for example, for the test strip 20, card slot depth is equivalentto, or greater than the thickness of the test strip. In general, inorder to save costs and miniaturize the detection apparatus, the widthof the card slot is slightly larger than the width of the test strip,the depth of the card slot is slightly larger than the thickness of thetest strip, and sometimes the width of the card slot is equal to orslightly less than the width of the test strip, the depth of the cardslot is slightly less than or equal to the thickness of the test strip.Because the card slot is located on the base layer (the middle diagramin FIG. 1A), just covering the base layer with a covering layer 101 canseal the entire card slot and the card slot forms a sealed channel, bythis way, the formed channel can accommodate testing element (the rightdiagram in FIG. 1A); for example, a sealed channel can accommodate adetecting area and a labeled area of a testing element. Of course,optionally, a sealed channel can accommodate a water absorption area, alabeled area and a test result area, and a test result control area of atesting element (FIG. 1C).

In general, firstly a base layer that comprises a card slot is provided.On one side of the base layer, a card slot with the length equal to thetest strip is opened on one side of the base layer, and the card slot iscompletely exposed, and then the test strip 20 is placed in the cardslot and let the test strip back side downwards (the side with asupporting structure 27), and front side upwards (the side where thedetecting area or the filter paper can be seen). A covering element 101is provided, which comprises a first covering area 810 and a secondcovering area 102, and an opening 103 between the first area and thesecond area. Finally, the covering element covers the base layer, sothat the first covering area 810 covers the testing area of the testingelement, and the second covering area covers a portion of the sampleapplying area, and let the opening 103 exposes a portion of the sampleapplying area. For example, in the position 102 in FIG. 1A, which isactually part of the covering element 101, part of the covering element810 covers the card slot, forming a sealed channel at one end foraccommodating part of the test strip element. The opening 103 on thecovering element 101 is used to expose part of sample absorption area 23of the testing element. Thus, one end of the card slot forms a samplechamber by a portion of the card slot on the base layer and the secondcovering area 102 of the covering element. The sample chamber is used tocollect samples. The height of the sample chamber depends on the lengthof a portion of the covering element 102. The volume depends on thedepth of the card slot and the height of the covering element 102.Therefore, the volume of the sample can be arbitrarily adjusted andchanged by the depth of the card slot and the height of the coveringelement 102. Usually, once the size of the test strip and the size ofthe card slot is determined, the volume of the sample chamber isdetermined, thus playing of role of fixing the sample volume. Inaddition, the first covering area 810 of the covering element and partof the card slot form a sealed channel, so that the test result area andthe labeled area of the testing element are located in the sealedchannel. It can be said that, due to the covering element opening 103,the entire sealed card slot is divided into two sealed channels, thesealed channel (sealed in one end, non-sealed in the other end, firstsealed channel) formed by the card slots covered by part of coveringelements 810 is used for accommodating part of the test strip elements,for example, the test result area and the labeled area of the testingelement, and this sealed channel is called the first sealed channel; andthe other sealed channel (the sealed channel formed by the card slotpartially covered by the covering element 102) forms sample chamber. Thetwo sealed channels are communicated with the outside through a commonopening 103, while the opening 103 is used to allow the fluid sample toenter the sample chamber. This makes it easy to collect fluid samplesfor quick and easy testing, as well as for freer testing. The testingcan be completed without requiring much specialized knowledge andskills, thus making testing easy and user-friendly.

FIG. 1B shows a specific form of a testing element. A test strip 20comprises a sample applying area 23 and a testing area 22. If possible,the test strip may further comprises a labeled area 26 and a sampleabsorption area 21, for example, testing area 22 is a nitrocellulosemembrane, and sample applying area is a glass fiber. The testing areamay comprise a test result area 24 and a test result control area 25.The labeled area 26 is at the downstream of the sample applying area 23and the detecting area 22 is at the downstream of the labeled area. Thedetecting area comprises a test result area 24 and a test result controlarea. The sample absorption area is at the downstream of the test resultcontrol area.

When assembling the detection apparatus of the present invention, a cardslot 100 is firstly formed on the base layer 104. The card slot can beformed by injection molding at one time, then the test strip 20 isplaced in the card slot 100, allowing one end of the liquid absorptionarea 21 of the test strip is located at the upper part of the card slot,and the sample applying area 23 is in the vicinity of the coveringelement opening, corresponding to the position of the opening 103.Finally, the base layer is covered with a covering element 101, and anopening 103 is opened on the covering element so that part of the sampleapplying area 23 of the testing element is exposed outside through theopening 103. In addition, the end portion of the testing element at thesample applying area 23 is inside the sample chamber (the left one ofFIG. 1A is an integral testing device 10, the middle one is a base layercontaining a card slot, and the right one is a covering element). Thetop view of a complete testing device is shown in FIG. 1C, with onlypart of the sample applying area of partial testing element is exposedoutside, and part of sample applying area is in the sample chamber.Here, the base layer can be transparent or non-transparent, while thecovering layer can be partially transparent. For example, the testresult area and/or the test result control area corresponding to thetesting element is transparent, so as to read the result of thedetecting area, while other parts can be non-transparent.

When testing is required, insert the testing device (as shown in theleft diagram of FIG. 1A or the diagram of FIG. 1C) into the liquidsample, such as urine, and the liquid sample enters the sample chamberin the card slot through the opening 103. The inserted depth may justsubmerge the entire covering element 102 constituting the sample chamberor any height above a portion of the covering element 102 and evensubmerge the entire testing device in the liquid sample. This allows theliquid to easily enter the sample chamber through opening 103. Wheninserted into the liquid sample, the testing device can be taken outimmediately or taken out after a while, then placed horizontally. Thetesting device can also be left in the liquid sample, by this way, asthe liquid sample enters the sample chamber, the liquid contacts thesample applying area, and the liquid flows from the sample applying area23 to the labeled area 26 along the test strip, and then flows to thetesting area at the downstream, finally absorbed by the absorption area21 (as indicated by the arrow in FIG. 1C). Due to the fact that samplesare also collected or retained in the sample chamber, they aresufficient for the test strip to absorb and complete the test, whichovercomes the drawbacks of the lack of liquid in the conventional art.Insufficient samples may cause unable to complete the testing; if theliquid is insufficient, it is unable to flow on the testing element, forexample, unable to flow continuously when only flowing to the upstreamof the test result area 24, or it is unable to wet the area due to verylittle liquid when flowing to the test result area 24.

The device of the present invention makes it easy, comfortable and freeto operate by the testers or operators. For example, the entire testingdevice can also be submerged in a liquid sample, which does not allowthe liquid to enter the sealed channel including the labeled area andthe detecting area (herein called first sealed channel, one end issealed, and the other is non-sealed through the opening 103 on thecovering element). Because the channel at this end is sealed and theother end will be sealed by liquid flowing through the opening 103, aportion of the gas is sealed within the channel. By this way, the liquidcan flow almost exclusively along the test strip from upstream todownstream based on the capillarity effect on the test strip, withoutadditional liquid entering the channel, avoiding too much test liquidfrom entering the first sealed channel, thus resulting in the so-called“flooding” phenomenon that may cause inaccuracy of the test result. Thismake it easy and convenient for testing, so that an operator (such as adoctor or laboratory inspector) can throw the detection apparatusdirectly into the liquid sample and wait until the reaction is completedor the test result is available, take out the detection apparatus toread the test results.

In addition, a conventional similar detection apparatus needs to beinserted into the liquid sample for a sufficient period of time, toobtain sufficient samples. In the present invention, a sample chamber isprovided at one end of the card slot and the end close to the sampleabsorption area of the test strip, which can be inserted into the liquidand taken out rapidly. Because adequate samples have entered the samplechamber, the testing efficiency is improved; especially when multiplesamples need to be detected in a limited time, this apparatus hasprominent advantages. The detection apparatus in the present inventionhas two sealed channels, which are communicated with the outside via theopening in the middle. The longer sealed channel accommodates thelabeled area, testing area and test result control area of the teststrip, and even the sample absorption area, while the shorter sealedchannel accommodates part of the sample applying area, and the openingexposes a part of the sample applying area, when one end of the sampleapplying area is immersed into a liquid sample, such as urine, just afew seconds is enough because the sample goes into the shorter secondsealed channel (forming a sample chamber) for reservation by openingduring the immersion, which can continue to provide fluid sample afterthe liquid sample is taken out subsequently. The liquid sample flowsfrom the upstream to the downstream of the test strip relying on thecapillary flow opening of the test strip at the moment of immersion inthe liquid sample, when taken out quickly, the liquid reserved in thesample chamber can continue to provide the liquid flow to complete thetesting. So the operating efficiency is improved significantly. Thetraditional card type detection apparatus similar to the invention hasno sample chamber, which will take more time to immerse the sampleapplying area of the test strip into the liquid sample, so the testingefficiency is not high.

In some other modes, since part of the covering element 810 covers partof the card slot, when the testing element is located in the card slot,the part of the card slot (part of the card slot covered by 810) issealed at one end; when the detection apparatus is inserted into liquidsample, the sample does not enter the channel formed by the card slotcovered by the partial covering element 810. Because one end of thechannel is sealed, the incoming liquid seals a part of gas in thechannel of the card slot, so that the liquid will not submerge thetesting area and the labeled area no matter how long the detectionapparatus is inserted in the liquid sample and how deep inserted in theliquid, thus ensuring the testing accuracy. In a more preferred mode,the labeled area and testing area on the testing element are covered andsealed by a portion of the covering element 810. More preferably, theopening 103 is located below the labeled area and retains part of thesample applying area 23. More preferably, part of the sample applyingarea is in the sample chamber (FIG. 1C). Unlike conventional card-typedetection apparatus, the detection apparatus thus formed does notrequire the operator to constantly check if the card-type detectionapparatus is correctly inserted in the liquid level for fear of havingenough time to contact the liquid sample, nor always check if theapparatus remains vertically in the liquid. The card-type detectionapparatus of the present invention can also be placed in the liquidsample at will. Even if the entire detection apparatus of the presentinvention is completely submerged in the liquid sample, the test resultwill not be affected since the liquid cannot enter the reagent area withdetection functions. By providing sufficient liquid sample at thelocation of the sample applying area, it can guarantee the amount ofliquid required for the testing. This will be further described withspecific embodiments below.

The above description is to illustrate how the apparatus of the presentinvention is implemented using a single test strip as an example. Ofcourse, the base layer may comprise a plurality of similar card slots.The covering element may cover and seal multiple card slot structures toform multiple openings. Each opening corresponds to a sample chamber,and each sample chamber is relatively independent, so that differentanalytes can be detected for the same fluid sample.

The base layer of the present invention can be rigid, such as plastic,aluminum alloy, etc. The covering layer can be a flexible or rigid.Optionally, the base layer and the covering layer are both rigid, andthe base layer and the covering layer are bonded; or the base layer isflexible, and the covering layer is rigid. In some preferred modes, thebase layer generally has a thickness, and the groove formed thereon hasa suitable depth and width which is covered with a thin film layer tocover and seal the groove. In some preferred modes, the base layer has acertain thickness, the covering layer also has a certain thickness, acard slot is provided on the base layer, and a card slot is alsoprovided on the covering layer. When the base layer and the coveringlayer are bonded face to face, their respective grooves correspond toform a channel. A testing element is disposed in the channel. An openingis provided either on the base layer or the covering layer, and theopening is located in the middle of the groove and at the end close tothe sample applying area of the test strip. By this way, a samplechamber is formed, and the sample chamber can accommodate some samples.For example, the opening 112 is not included on the base layer, butopening 112 (FIG. 1C) is provided on the covering element, and theopening is communicated with the sample chamber, or the opening 112 isprovided on the base layer but not provided on the covering element(FIG. 8); Or, the opening 112 is provided both on the base layer and thecovering element at the same position, and the two openings arecommunicated with the sample chamber.

In some preferred modes, the base layer is rigid, with multiple cardslots on the base layer, or the covering layer is transparent andflexible, or partially transparent, and in particular, the partcorresponding to the testing area is transparent. In other preferredmodes, the base layer is not transparent and the covering layer istransparent; alternatively, the base layer is transparent and thecovering layer is not transparent. When the front of the testing elementfaces the base layer, the base layer can be completely transparent orpartially transparent, or the base layer can be transparentcorresponding to the testing area and/or labeled area on the testingelement (FIG. 3). Optionally, when the front of the testing elementfaces the covering layer, the covering layer may be completelytransparent or partially transparent, or the covering layercorresponding to the testing area and/or the labeled area on the testingelement is transparent (FIG. 1C), while the base layer can betransparent or opaque.

The method of forming a card slot on the base layer can be completed byone-time injection molding or by laser etching. The rigid base layer canbe made, for example, of a “thermoplastic” material, which here refersto a hot-melt plastic polymer that becomes fluid when heated andsolidify into a glass substance when cold enough. This thermoplasticmaterial can be a polymer of high molecular weight, and its linksbetween chains rely on weak Van der Waals' force, stronger dipole-dipoleinteractions and hydrogen bonding or aromatic ring packing.Thermoplastic materials may include additional components, such aslaser-sensitive materials. Some examples of thermoplastic materials maybe acrylonitrile butadiene styrene (ABS), Poly MethylMethacrylatemethacrylic Acid (PMMA), celluloid, cellulose acetate orcellulose acetate, Cyclic Olefin Copolymer (COC), ethylene vinyl acetate(EVA), ethylene vinyl alcohol (EVOH), fluoroplastics (PTFE with FEP,PFA, CTFE, ECTFE, ETFE), ionomers, acrylic/PVC, alloys, LCP,polyethylene (POM or acetal), polyethylene (acrylic acid),polyacrylonitrile (PAN or acrylonitrile), polyamide (PA),polyamide-imide (PAI), polyaryletherketone (PAEK or ketone),polybutadiene (PBD), polyethylene (PB), polyethylene terephthalate(PBT), polycaprolactone (PCL), polychlorotrifluoroethylene (PCTFE),polyethylene terephthalate (PET), ethylene terephthalate (PCT),polycarbonate (PC), polyhydroxy fatty acids (PHAs), Polyketide (PK),polyester, polyethylene (PE), polyetheretherketone (PEEK),polyetherketoneketone (PEKK), polyetherimide (PEI), polyethersulfone(PES), polyvinylchloride (PEC), PI, PLA, PMP, PPO, PPS, PPA, PP,polystyrene (PS), polysulfone (PSU), polytrimethylene terephthalate(PTT), polyurethane (PU), polyvinyl acetate (PVA), polyvinyl chloride(PVC), polyvinylidene chloride (PVDC) and polystyrene-acrylonitrile(SAN).

The covering elements can be polymer-formed flexible covering elementsmade by such materials as plastic films, double-sided tapes, polymers,etc. The element can cover a rigid base layer to seal the card slot inthe rigid base layer. It can also be made of a thin layer materialformed by the above base layer material, or a thin layer flexiblematerial formed. The concept of “rigid” and “flexible” herein isrelative rather than absolute.

In some other embodiments, as shown in FIG. 3, the detection apparatusof the present invention comprises a base layer 30, and the materialforming the base layer may be plastic and it is formed by injectionmolding at one time. One or more card slots 100 are disposed on the baselayer 30, and the card slot has a certain depth and width, the width ofthe card slot is the same as the width of the testing element, or equalto or slightly greater than the width of the test strip. The length ofthe card slot is equivalent to or slight longer than the length of thetest strip (FIG. 3 shows the back of the base layer). Preferably, oneend of the card slot and one end close to the base layer 130 areprovided with a fixing structure, for example, a pair of protrudingtenon structures 108 and 1081 which are respectively disposed on theopposite side walls 1002 and 1003 (FIG. 4) that constitute the cardslot. The protrusion keeps the testing element in a relatively fixedposition in the card slot.

There is an opening 112 at one end near the base layer 132, one opening112 is provided at each card slot, but the opening is not disposed atthe bottom end 132 of the card slot, but a certain position 902 isreserved (FIG. 7). The portion 902 reserved in the front side and thecovering element subsequently covered on the card slot form a samplechamber (FIG. 8), by this way, when a multiple of card slots are formedon the base layer, a sample chamber is formed at one end 132 of eachcard slot, so, there is a test strip in each sample chamber or a part ofsample applying area is accommodated in each sample chamber, and eachtest strip can be used to test different analytes. Each sample chamberforms a relatively independent space due to the side wall of the cardslot. These sample chambers are independent of each other and cannotexchange liquid. In this way, the same type of liquid sample exits inthe multiple sample chambers. However, since the testing elements areset for different analytes, multiple different analytes can be detected.In this way, a liquid sample can be used to test a variety of differentanalytes simultaneously, in addition, it avoids mutual interferencebetween test strips with different test substances, since each samplechamber is relatively independent. Additionally, the test strip (testingarea, labeled area) with the test substance is sealed within thechannel, typically within the longer longitudinal channel, and a shortersealed channel (sample chamber) is formed at the other end of the cardslot in another end of the card slot, which can only accommodate part ofthe sample applying area, to prevent the mutual influence betweendifferent test strips.

Of course, optionally, each card slot can exist not independently at theposition of opening 112, but there is no partition 1120 in the opening,forming an area without partition, which is also feasible (the partitionstructure as shown in FIG. 4). Of course, optionally, a sample chamberusually corresponds to a test strip. Of course, the side walls of thecard slot that forms the sample chamber can also be removed. In thisway, multiple test strips share a large sample chamber.

In addition, the card slot comprises a structure that reduces, preventsor limits capillary flow. In the card slot designed in this way, thereare mainly two locations where the capillary gap is generated; one isthe distance between the side of the test strip and the side wall of thecard slot that may generate a capillary gap, thus causing capillaryflow. Such capillary flow is undesirable because the resulting capillaryflow causes liquid to flow to the downstream area earlier than thatflowing based on capillary effect of the test strip itself, thus theliquid earlier will dissolve or wet the test strip and cause abnormaltesting, called abnormal liquid samples or extra liquid samples. Becausethe abnormal capillary flow is only the flow of liquid samples and thenormal liquid that depends on the capillarity of the test strip itselfcan dissolve the reagents on the test strip, such as labeling reagents,reagents for handling liquid samples, etc., the detection accuracy andsensitivity will not be affected. In general, it is required to minimizethe abnormal liquid into the sealed channel and allow more normal liquidto be absorbed by the test strip, so as to make the result moreaccurate; on the contrary, if the entry of abnormal liquid is notcontrolled, the capillary action on the test strip will be affected,which eventually leads to inaccurate test results.

As shown in FIG. 4, for example, a pair of tenon structures 1008 and1018 is also provided on the side wall of the card slot adjacent to theopening 112. The structure can play a role of fixing the test and otherfunctional meanings. This structure can reduce, prevent or limitcapillary flow. For example, the structure can protrude from the sidewall, and when the width of the testing element is equal to or close tothe width of the card slot, put the testing element into the card slot,and the protruding tenon squeezes the test strip, leaving a distancefrom the side of test strip to the side wall of the card slot. Thedistance is greater than the size for forming capillary, thus unable toform a capillary flow. By this way, the tenon plays a role of reducingor restricting the capillarity. In addition, even though it is possibleto have a capillary gap between the test strip and the side wall of thecard slot, the tenon structure is in tight compression and contact withthe test strip; and the liquid from the upstream of the tenon is blockedat the tendon, so that the liquid cannot continue to flow downstreamalong the capillary gap, to prevent the liquid passing through thecapillary gap from reaching the downstream area earlier than the liquidfrom the test strip, such as the labeled area or detecting area.Usually, the location of such a protruding card structure is preferablyat the upstream of the labeled area or at the downstream of the sampleapplying area or at the upstream of the detecting area or disposedcorresponding to the labeled area. Preferably, such a structure thatreduces, prevents or limits capillary flow is generally disposed withina first sealed channel. This structure that reduces, prevents or limitscapillary flow have another advantage when disposed at the upstream ofthe labeled area: in some cases, this structure will not allow moreliquid to enter the first sealed channel, so that the first sealedchannel is definitely sealed by the incoming liquid to form a part ofclosed gas in the first sealed channel, thereby ensuring independenttesting of the testing element. When the liquid enters the first sealedchannel through the opening, microscopically it is a gradual process,and it is always hoped that the liquid will not enter the channel anylonger when entering the first sealed channel through the opening, andthe tenon structure at the upstream of the labeled area acts as abarrier to prevent liquid from entering the channel, thus ensuring thesealing performance of the liquid. In this way, we need not to worryabout that the liquid will enter the first sealed channel even if theapparatus in the present invention can be immersed in the liquid sample,or even free to throw into the liquid sample, which may cause abnormalliquid to enter the first sealed channel.

In some preferred modes, the structure that reduces capillary flow, forexample, the tenon structure, is located at the upstream of the labeledarea of the testing element, or at the downstream of the testing area,or at the upstream of the sample chamber; preferably, the groove of thestructure that reduces capillary flow is located at the upstream of thelabeled area of the testing element, or the structure that reducescapillary flow is disposed corresponding to the labeled area of thetesting element. In some preferred modes, the capillary flow is thecapillary space formed between a test strip and a card slot, or thecapillary gap formed between a test strip and the bottom of a card slot.Further, a similar tenon structure may be some other structure as longas it has one or more functionally similar structures as describedabove. For example, the tenon structure actually protrudes upward fromthe surface of the side wall of the card slot, higher than the side wallplane, so that the card slot becomes narrow at the tendon. The tendoncan be distributed on the surfaces of two side walls symmetrically, ofcourse, not necessarily distributed symmetrically. In addition, theremay be a number of structures that reduce, prevent or limit thecapillary flow, and these structures can be distributed anywhere in thecard slot, either as a single tenon structure or as multiple tenonstructures that are distributed randomly rather than symmetrically. Ofcourse, such a structure may have a recess in the side wall of the cardslot, which does not enhance the stationarity of the test strip in thecard slot, but increases the distance between the side of the test stripand the side wall of the card slot, and the distance is greater than thedistance of capillary action. The recess may be located at the upstreamof the labeled area of the test strip, which is at the downstream of theopening or at the downstream of the non-sealed end inlet of the firstsealed channel.

In some preferred modes, as shown in FIG. 4, a card slot furthercomprises additional structure that reduces, prevents or blocks thecapillary flow. The structure can minimize the flow of liquid samplealong the capillary structure (another position that may producecapillary flow) formed between the test strip and the bottom 1001 ofcard slot, so as to maximize the liquid sample flow along the test striponly. When the test strip is placed in the card slot, usually the frontside of the test strip (the side where the testing area and the labeledarea can be visually observed) is in direct contact with the bottomsurface 1001 of the card slot, thus, a gap structure, such as acapillary gap structure, will be formed between the bottom surface 1001of the card slot and the test strip. When the detection apparatus isinserted (immersed) into the liquid sample as described above, part ofthe liquid samples is absorbed by a portion of the sample applying area,part of them enters the sample chamber, and part of them may flowupwards by forming capillary gap between the bottom 1001 of the cardslot and the front side of the test strip, causing the liquid sample towet the labeled area or testing area earlier, while the liquid from thetest strip will be delayed to reach the labeled area and testing area,thereby, resulting in inaccurate test results. When serious, it willcause the test strip not to work.

In order to avoid such problems, the card slot in the invention furthercomprises a structure that reduces capillary flow. The structure canreduce or prevent capillary flow of liquid outside the test strip. Thatis, the capillary structure allows the liquid to flow on the testingelement through the capillary force of the test strip, and reduce theflow of capillary gap formed between the test strip and the card slot.In some preferred modes, as shown in FIG. 4, the structure that reducescapillary flow beyond the test strip is located on the bottom 1001 ofthe card slot; the structure is one or more grooves 1004, 1005 and 1006,these grooves can absorb part of liquid samples, to prevent the liquidsamples from continuing to flow along the capillary gap formed by thetest strip and the bottom of the card slot. There are one or more groovestructures as shown in FIG. 4. The grooves form a “Y” shape, or anyother shapes such as a cross or a letter shape, or round, rectangle,square, diamond, oval, etc. Of course, the groove is only one of thestructures that reduce the capillary flow, and there are otherstructures, such as hole, cavity, trace or channel, and so on. Thesestructures can adsorb liquid samples or prevent liquid samples fromcontinuous flow through a large surface area, for example, onceencountering the structure that reduces capillary flow, the liquid willbe adsorbed or blocked, unable to or substantially unable to flowforwards or towards the downstream.

These structures that reduce capillary flow can distribute on the bottomsurface 1001 of the entire card slot or can be restricted in somepositions. Preferably, these structures that reduce capillary flow arelocated at a position of the card slot. In some modes, these structuresthat reduce capillary flow are located at the upstream of the test striplabeled area 26. When the liquid passes through the capillary gap formedbetween the bottom of card slot and the test strip and flow upwards, theliquid will be stopped or reduced at the position due to the presence ofstructures that reduce capillary flow, thus, the liquid samples will notwet the labeled area in advance. In some preferred modes, the structurethat reduces capillary flow is located at a corresponding position inthe labeled area.

In some preferred modes, the structure that reduces capillary flow islocated at the downstream of the opening 112 and the upstream of thelabeled area. Alternatively, the structure that reduces capillary flowis located on the bottom 1001 of the card slot near the opening.

In some preferred modes, the structural attachment that reducescapillary flow may also include another pair of structures 1018, 1008that secure the test strip so that the card slot has a fixed structureof different locations that allows the test strip to be secured in thecard slot (FIG. 4). As shown from FIG. 4 and FIG. 3, the card slot 100has a bottom 1001 and the side walls 1002 and 1003 formed by twocorresponding edges. The two edges define the depth of the card slotwhile the bottom 1001 defines the width of the card slot. When the cardslot is formed on the base layer, the base layer has a certainthickness, so that a certain depth of groove can be easily andconveniently formed on the base layer to place the testing element witha certain thickness. In fact, the base layer for forming a card slot hastwo sides: one side for opening the card slot (may be referred to as theback side of the base layer) and the other side as the bottom 1001 ofthe card slot (may be referred to as the front side of the base layer).As the bottom surface 1001, the thickness of the card slot may be 1 mmto 8 mm, for example, for the thickness marked as 1007, it may be 1 mmto 8 mm, such as 1 mm, 2 mm, 4 mm, 5 mm, or 8 mm, etc. The thickness ofthe base layer can be arbitrarily chosen according to different needs.Here, the bottom 1001 of the card slot is not complete, but rather has ahollow structure at a distance. That is, the hollow forms the opening112, but not the whole bottom 1001 of the card slot is hollow. Thehollow is in the middle and two parts are reserved, one part is used tosupport the detection area of the test strip or to form a structurereducing capillary flow, and the other part is used to form a part ofthe sample chamber. The formed hollow opening 112 may be of any length,any area, any shape, e.g. rectangle, square, circle, diamond, generallythe opening is used for receiving the liquid sample into the samplechamber, in addition, the opening is used for exposing part of the teststrip, for example, exposing part of the sample applying area.

In addition, in order to better secure the test strip, the test strip isplaced in the card slot in a balanced manner. A slightly convex area isprovided at the bottom of the corresponding card slot of the tenons1008, 1018, for example, as shown in the figure, the position of areas1130 and 1131 is slightly higher than that of the area 1132. The twoareas are higher than the area 1132 by 1 mm, 2 mm, or others.

The back of the base layer is shown in FIG. 3, the front is shown inFIG. 8. When the testing element 20 is placed in the card slot, one endof the water absorption area 21 of the testing element 20 (FIG. 2) isclose to the 3nd 130 of the base layer, while the end with the sampleapplying area 23 is close to one end of base layer 132, and the sampleapplying area with the absorbent material faces the front, an absorbentmaterial of the sample absorption area such as glass fiber or otherfibrous material (FIG. 1C or FIG. 10, or FIG. 2) can be seen through theopening 112. After placing the test strip, cover the back of the baselayer with a flexible cover layer 900 (FIG. 8), sealing the entire cardslot 100. Thus, the entire card slot at the back of the base layer iscovered by the covering layer (FIG. 7). At this time, a sample chamber(second sealed channel) is formed near each end of the base layer 132 ateach card slot. A portion of sample applying area 23 (FIG. 10) of thetesting element is located in the sample chamber with part of the sampleapplying area exposed in opening 112, and the rest parts, such as thelabeled area, testing area and absorption area, are covered by thecovering layer and sealed to the card slot close to the other end of thebase layer 130 (front side shown in FIG. 9), that is the so-called firstsealed channel, both of which have entrances, in addition, the twochannels are partially partitioned by the opening 112 and are alsocommunicated with the outside. When the base layer is a transparentplastic, you can see the testing area and the labeled area through thefront of the base layer. Of course, the direction of the test strip canalso be the opposite to the above examples, so that the back of the teststrip (the side with the supporting sheet 27) rests directly on thebottom 1001 of the card slot, leaving one side of the sample absorptionarea, detecting area or absorption area or labeled area is disposedfacing towards the covering element. By this way, the covering element900 covers the back of the base layer so as to seal the entire cardslot, but the covering element is transparent, what is seen through theopening 112 of the base layer is the back of the support surface 27where the sample applying area of the testing element is located, ratherthan the front side with the absorbent material. When testing, throughthe transparent covering element you can see the test results of thedetecting area on the testing element. At this time, the coveringelement does not provide an opening 112, but only an opening 112 isprovided on the base layer.

Of course, the opening element 112 can be formed simultaneously on thecovering element and the base layer. The shape and size of the openingcan be the same or different, so that two openings are formed tocommunicate with the sample chamber. When it needs to detect analyte inthe liquid sample, insert the testing device consisting of the baselayer, test strip and covering element into the liquid sample, insertone end with the opening 112 into the liquid sample and then take out,and allow the liquid samples to flow along the reagent strip from thesample applying area to the labeled area, then flow to the testing area,after passing through the test result area and the test result controlarea, and finally reach the absorption area to complete the test.Because sufficient samples are retained in the sample chamber, enoughliquid can be provided to flow on the test strop and avoid the drawbacksof insufficient liquid samples in the conventional art. In addition, itis simple to manufacture such testing devices, with low cost. The baselayer can be completed in one time, and the test strips are existingones, then a covering element is covered, to complete the process. Theproduction steps are simple and fast. In addition, as mentioned above,the detection apparatus can be completely immersed in the liquid sampleto be tested directly. No matter what placing means is used, how longthe time of immersion in the liquid sample, the liquid can flow normallyon the test strip, to obtain the correct results. Unlike the traditionalsimilar detection apparatus, this eliminates a lot of restrictions foroperators.

In some preferred modes, the detection apparatus further comprises anexhaust, decompression or depressurization structure, one end of thestructure is in gas communication with the sealed channel and the otherend is in fluid communication with the outside atmosphere. The structureis used for exhausting part of the gas in the sealed channel, especiallywhen the liquid enters the sealed channel, as a part of gas is sealed inthe channel by the liquid, the pressure increases to prevent liquid fromentering. In fact, in order to make the test card small and lower thecost, the width and thickness of the card slot is slightly larger thanthe test strip, by this way, when the test strip is in the card slot,the test strip is surrounded by the card slot, so the test strip is thechannel packed by the card slot and covering layer. When the liquidenters the channel entrance (for example, the sealed channel entranceand the sample chamber opening are the same one), the liquid easilyseals the channel entrance. The structure is designed to allow for theelimination of gas, allowing the liquid to enter the sealed channel toprovide sufficient liquid samples. In some preferred modes, as shown inFIG. 4, the exhaust structure is located in the bottom 1001 of the cardslot. There are one or more exhaust structures, and multiple grooves1004, 1005 and 1006 are as shown in FIG. 4. The grooves form a “Y”shape, or any other shapes such as a cross or a letter shape, or round,rectangle, square, diamond, oval, etc. Of course, the groove is only onekind of the exhaust or decompression structures, and there are otherstructures, such as hole, cavity, trace or channel, and so on. When theliquid enters the sealed channel, one end of these grooves is incommunication with the gas in the sealed channel and the other end is incommunication with the gas of the outside atmosphere, so that excess gascan be removed and more liquid enters the sealed channel. Once thegroove structure is sealed by liquid, the inside and outside theatmosphere of the sealed channel achieves a balance, and the liquid willno longer enter the channel. In some preferred modes, one end of thegroove that is in communication with gas of the outside atmosphere isconnected to opening 112, and the gas in the channel is removed throughthe opening.

These exhaust structures can be distributed in the entire bottom surface1001 of the card slot, or limited to some locations. Preferably, theseexhaust structures are located somewhere in the card slot. In somemodes, these exhaust structures are located at the upstream of the teststrip labeled area 26. In some preferred modes, the exhaust structure islocated at the corresponding location of the labeled area. The exhauststructure is one or more grooves 1004, 1005, 1006, which allow the restin the channel to be discharged to the ambient atmosphere. There are oneor more groove structures, as shown in FIG. 4. The grooves form a “Y”shape, or any other shapes such as a cross or a letter shape, or round,rectangle, square, diamond, oval, etc.

Here, the exhaust groove structure and the groove that reduces capillaryflow as described above can be the same structure. The structure hasdual functions, one is to reduce capillary action, and the other isexhausting and reducing pressure. Of course, the two structures can bedifferent, with their respective functions.

In some preferred modes, the sample chamber is located at one end of thebase layer and near the sample applying area of the test strip. As shownin FIGS. 3, 5 and 6, the sample chamber is formed by a part of the cardslot 902 on the base layer surrounded by the covering element 900.Because the base layer has a certain thickness, the card slot on thebase layer has a depth, the depth of one end of the card slot close tothe base layer 132 is determined by the height of the bottom 107 of thecard slot. The structure area 107 constitutes the bottom area of thesample chamber, while the covering element and another area 110 at thebottom of the card slot isolated by the opening, and the two partialedges 125, 127 of the card slot form the side wall of the samplechamber, thus forming the sample chamber in the invention. The samplechamber accommodates sample applying areas of some testing elements. Insome preferred modes, a protruding structure 111 is provided upwardsfrom the bottom 802 of the card slot in the bottom area 107 close to thesample chamber. The protruding structure allows the the sample applyingarea of the test strip close to the covering element 102, to play a roleof fixing test strip. In addition, some spaces are reserved toaccommodate more liquid samples. The test strip has a certain thickness,the height of the protruding structure 111 is slightly shorter than thedepth of the card slot and the difference in the height is equal to thethickness of the test strip. Since the sample applying area of the teststrip is usually of glass fiber with elasticity, the protrudingstructure 111 can press the support sheet on the back of the sampleapplying area of the test strip to close to the covering element. Inaddition, the test strip has a certain thickness, and the depth of thecard slot is slightly larger than the thickness of the test strip in acertain range, usually 2-5 mm. When one end of the test strip is locatedin the sample chamber, it occupies the most of the volume of the samplechamber. By this way, it is difficult to allow the sample chamber toaccommodate more liquid sample to wet the test strip completely,therefore, on the one hand, a protruding structure 111 can be providedto compress the soft sample applying area material, and on the otherhand, it can reduce the thickness of the bottom of the card slot, forexample, with a bevel 115. The bevel reduces the thickness of the bottomof the card slot, thereby increasing the volume of sample chamber. Inaddition, if the test strip is located too close to the bottom of thecard slot (beveled position) in the sample chamber, a capillary gap willbe formed, so that the liquid sample will not easily enter the samplechamber; moreover, due to the complex structure of the capillary gap,the volume of the sample chamber in a card slot is also different,increasing the inaccuracy and uncertainty of the test. Therefore, in theplace close to the opening 112, the side wall of the sample chamber (forexample, the bottom 1001 of the card slot) is thinned and the distancebetween the card slot and the test strip is increased to allow theliquid sample to enter the sample chamber. At the same time, itincreases the volume of sample chamber, to provide enough liquid sampleto complete the wetting of the test strip. Of course, in order toincrease the sample chamber volume, the side wall (the area 110 of thebase layer thickness and two opposite sides 125, 127 that form the cardslot) that surrounds the sample chamber can be thinned, or depressedholes are provided on these side walls. Although these methods arefeasible, it is more preferred to allow the area of the bottom 110 ofthe card slot to be thinner. With the above sample structure, thecard-type detection apparatus is more compact, but it does not affectthe superior performance of the present invention. So the cost is lowbut the performance is more superior.

In some preferred modes, a cover body component can be provided. Whenthe detection apparatus is inserted into liquid sample, take out thedetection apparatus, allow one end of the opening 112 to insert thecavity 12 of the cover body component 10, to protect the sample contactarea from contamination. To limit the depth of the cover body,symmetrical limiting structures 30, 31 may be disposed on the base layerto limit the depth of the cover body insertion (FIG. 11A-B). In order toincrease the stability of the cover on the base layer, two protrudingfastening strips 13, 14 are provided inside the cover. When one end ofthe base layer is inserted into the cover body, the fastening strips 13,14 increase the adhesion force between the cover body and the baselayer, so that the cover body is not easily fallen off, thus preventingleakage of liquid sample from the opening 112 at one end of the baselayer that will cause contamination of the external environment. Anextended portion 11 is included at the bottom of the cover body, whichis used to guide one end of the detection apparatus opening 112 to enterthe cover body component 10, and prevent operators from contacting thesamples. The edge of the cover body extension portion 11 also has acover edge 15 higher than the bottom surface (higher than the planewhere the extension surface is located) so that the liquid contained inthe detection apparatus can be prevented from being leaked when thedetection apparatus is taken out from the liquid sample, to avoid thecontamination on the external environment. In some preferred modes, thefastening strips 13, 14 are arranged opposite to the extension portionso that the base layer is inserted into the cover body from a singledirectional position.

In another more preferred mode, if there is fewer liquid sample, theliquid sample can hardly enter the sample chamber through the opening112 when the end of the detection apparatus with the sample chamber isinserted into the liquid sample, so that the testing element cannot bewetted. At this time, the detection apparatus must be inclined, whichwill increase the difficulty of operators. To better overcome such adetection apparatus, some liquid channels are provided on the samplechamber or the accessory, so that the liquid is in fluid communicationwith the sample applying area of the test strip. Preferably, theseliquid channels are arranged at a position lower than opening 112. Thisallows fluid samples to be fluidly connected to the sample applyingareas of test strips through these liquid channels, even though someliquid levels are lower than the opening 112.

For example, as shown in FIGS. 12-16, it is yet another more preferredembodiment of the present invention. The liquid channel 1046 is disposedat the bottom of the collection chamber with the end portion 1047 of thesample applying area 23 of the test strip exposed from the liquidchannel 1046, in this way, when the end with the opening 112 is insertedinto the liquid sample, the end portion 1047 of the sample applying areais brought into contact with the liquid sample. Of course, optionally,these liquid channels may not expose the sample applying area of thetest strip, instead, the liquid channel is opened and the test stripdoes not occupy the channel space. By this way, the liquid is allowed topass through the channel into the sample chamber to contact the sampleapplying area of the test strip. In some modes, the liquid channel 1046is in rectangular shape, with the size of the channel being adapted tothe size of the test strip, to substantially expose the end portion ofthe test strip, for example, exposed by 1-2 mm, 2-3 mm. In this way, thesetting of the opening 112 and the liquid channel 1046 can satisfy morecircumstances, without special limitation on the amount of liquidsample. Of course, the end portion 1047 of the test strip may not beexposed, but located inside the liquid channel. The size of the liquidchannel 1046 is generally adapted to the size of the test strip. Forexample, it is slightly larger than the size of the test strip. The gapbetween the size of the liquid channel and the size of the end portionof the test strip will not allow liquid samples to drip down naturallybecause of the surface tension. If there is more liquid, for example,when the detection apparatus is inserted into the liquid sample, theliquid level is in the A position, the liquid sample can enter thesample chamber through the opening 112, and the liquid sample can passthrough the liquid channel 1046 to contact the sample applying area ofthe test strip. This means that even after the liquid sample isinserted, the apparatus will be taken out in a short period of time,which firstly ensures that the liquid can be in adequately contact theliquid sample, and then the liquid sample remains in the sample chamber,to provide adequate liquid samples for the continuous flow in the teststrip. The liquid channel is provided on the sample chamber, having theadvantages. Usually the sample chamber has a small volume and the teststrip is inserted in the sample chamber. If the liquid sample is passedthrough the opening 112 into the collection chamber, more space isprovided to accommodate liquid samples, in addition to reduction of thethickness of the wall of collection chamber as described in theinvention. But in fact, the space of sample chamber is still limited,and the liquid cannot easily fill the sample chamber quickly. Althoughthe size of the sample chamber can be set, the size of the test strip isnot always the same. This will produce a problem: each sample chambercollects different liquid sample within a period of time, so the volumeof the liquid sample provided to each test strip is not the same,affecting the test results. However, when the liquid channel 1046 isdisposed on the sample chamber, the liquid can fill the sample chamber(formed by the second sealed chamber) rapidly once the liquid level ishigher than the opening 112. Because the air in the sample chamber canbe eliminated through the liquid channel, accelerating the time andeffectiveness of filling the sample chamber by liquid, basically it justtakes 1 to 3 seconds to fill the sample chamber. At this time, theliquid channel 1046 can eliminate the air in the sample chamber to allowthe liquid sample to quickly fill the collection chamber; in addition,it can allow the liquid sample to pass through the liquid chamber tocontact the sample applying area 23 of the test strip. The requirementsfor the setting of channel size: when liquid samples are filled orstored in the sample chamber, the liquid samples in the sample chamberwill not flow out through the liquid channel after the detectionapparatus leaves the liquid samples. The liquid has a surface tensionand the channel size should consider the maximum volume of liquidcontained in the sample chamber. The size of the liquid channel is setto allow the liquid in the sample chamber not to flow out of the liquidchannel 1046 due to surface tension. By this way, such a detectionapparatus can satisfy different sample tests, in addition, it improvesdifferent applications of detection apparatus, especially when theliquid sample is very good, the setting is particularly effective.

If there are fewer liquid samples, for example, at the position ofliquid level B, although the liquid samples will not enter thecollection chamber through opening 112, they can pass through the liquidchannel 1046 to contact the sample applying area 23 of the test strip,to complete the testing.

Usually the liquid samples enter the sample chamber from the opening112. The liquid stored in the collection chamber is not easily leakedthrough the liquid channel 1046 because of the size of the liquidchannel, thus ensuring the continuous flow of the subsequent liquid fromthe collection chamber to the test strip, to complete the entire test.Here, the shape of the liquid channel may be a rectangle as shown inFIG. 12, or a circle, a diamond, a square, an ellipse, and a combinationof these shapes.

In addition to the liquid channel disposed at the bottom of thecollection chamber as shown in FIG. 12, more liquid channels can bedisposed at other places. The principle for setting: Some structuressimilar to liquid channel are disposed at the positions lower than theopening 112, to increase the opportunity of the sample applying area 23of the test strip to contact the liquid (the liquid level is lower thanthe opening 112 when the liquid is less) and facilitate the operation.In addition, it can overcome some drawbacks when there is less liquid.These positions can be any position below the opening, for example,opening a channel on the wall of the sample chamber, or opening one ormore liquid channels on each sample chamber. It should be noted that,these additional liquid channels designed are not essential but apreferred embodiment of the present invention.

Assembly Method of a Detection Apparatus

The present invention provides a method of manufacturing a detectionapparatus which is simple and inexpensive. In some modes, a disposableinjection molded base layer is provided that comprises a card slot asshown in FIG. 3 with a certain depth and width. The width of the cardslot is equivalent to the width of the accommodated testing element,which can be equal to or slightly greater than the width of the teststrip; the length of the card slot is equivalent to or slightly longerthan the length of the test strip (FIG. 3 shows the back view of thebase layer and the FIG. 8 shows the front view of the base layer).Preferably, one end of the card slot and one end close to the base layer130 are provided with a fixing structure, for example, a pair ofprotruding structures 108 and 1081. An opening 112 is provided at theend close to the base layer 132, and an opening 112 for each card slot.But the opening is not provided at the bottom end 132 of the card slot,but a certain position 102 is reserved (FIG. 5), as the previouslydescribed hollow opening 112. A testing element is provided, comprisinga sample applying area, a labeled area, a testing area, and a waterabsorption area. The sample applying area is located at the upstream ofthe labeled area. The testing area is located at the downstream of thelabeled area. The testing area comprises a test result area and a testresult control area (FIG. 1B and FIG. 2). The test strip is placed inthe card slot so that one end of the sample applying area corresponds toopening 112 of the card slot, and the one end of the absorbent area isnear the end of the base layer 130; in addition, a portion of the sampleapplying area is inside the sample chamber and relies on the protrudingstructure 111 inside the sample chamber. Additionally, the labeled areaof the reagent strip is located at the upstream of the structures thatreduces the capillary flow, while leaving the side of the test stripwith support sheet 27 exposed through the card slot. A flexible coveringlayer is provided that covers the back of the base layer to seal theentire card slot while bonding the surface of the test with thesupporting sheet 27; at the same time, the covering element such asdouble-sided tape, bonding films, etc., and the portion 902 of the frontside of the card slot forms a sample chamber, exposing a portion of thesample applying area through opening 112, and the labeled area andtesting area are sealed in the card slot (first sealed channel) by thecovering layer. Of course, the base layer may comprise a plurality ofsimilar card slot structures. The covering element is adapted to thesize of the back of the base layer, and only one covering element isrequired to seal multiple card slots (forming a plurality of similarfirst and second sealed channels). Thus, testing elements are placed ineach card slot for testing different analytes, to form a sample chamberin each card slot. Multiple different analytes can be detectedsimultaneously for the same sample.

Detection Method

In another aspect, the present invention provides a method of detectinganalyte in a liquid sample, comprising: inserting the detectionapparatus in any of the foregoing modes into a liquid sample and soakingat will to liquid sample, then taking out and reading the test resultson the testing area through the front of a transparent base layer or acovering element. It can be read by naked eyes or by a machine, forexample, quantitative reading by the machine designed according to theoptoelectronic principle or scanning to save the test results through ascanner. The time from insertion, soaking at will to the liquid samplecan be 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds,7 seconds, 8 seconds, 10 seconds, 12 seconds, 15 seconds. After takenout, assay or testing can be carried out by a test strip.

Inserting herein means that, firstly contacting the end with samplechamber with liquid samples, then taking out, or firstly contacting theend with sample chamber with samples, then continuously inserting toallow the whole detection apparatus to be immersed in the liquid sample.

Example 1

Referring to FIGS. 2-8, a detection apparatus of the present inventionis provided with a plastic rigid base layer structure. Eight card slotswith the same structure are provided on the rigid base layer as shown inFIG. 2. Each test strip can be used to detect analytes such asamphetamine, cocaine, methamphetamine, opiates, THC and phencyclidine inurine, respectively. Using gold particles as a labeling material, theseanalytes are detected by the competitive methods. The front side of thetest strip is mounted to a card slot in the direction of opening 112,and the absorbent material on the sample applying area of the test stripcan be seen from the opening 112, such as glass fiber, and thentransparent adhesives with the same size as the base layer are coveredon the back of the base layer, thus forming a detection apparatus.

Fifty negative samples are mixed with mixtures of drug abuse, includingamphetamines, cocaine, methamphetamine, opiates, THC andphenylcyclohexane, in addition, 50 negative samples are provided.

When testing, insert the detection apparatus (detection card) into theseurine samples and immerse them in the urine for 30 seconds, 1 minute, 2minutes, 3 minutes, 5 minutes, or let the entire detection apparatusfreely throw into the liquid sample for soaking for more than 1-15minutes, to detect by the detection apparatus. Eventually, the flow ofliquid can be completed correctly to get effective results, indicatingthat the apparatus is more casual and user-friendly while ensuring theaccuracy of the results.

Example 2

In contrast to Example 1, a detection apparatus as shown in FIGS. 12-16is provided, with a liquid channel 1046 on the bottom of each samplechamber. The size of the test strip is 2 mm thick and 6 mm wide. Thevolume of the sample chamber (without the test strip) is 2 ml. Thelength and width of the liquid channel are mm, respectively.

Fifty negative samples are mixed with mixtures of drug abuse, includingamphetamines, cocaine, methamphetamine, opiates, THC andphenylcyclohexane, in addition, 50 negative samples are provided.

When testing, insert the detection apparatus (detection card) into theseurine samples and immerse them in the urine for 1 second, 3 seconds, 5seconds, 7 seconds, 9 seconds, 1 minute, 2 minutes, 3 minutes, 5minutes, or let the entire detection apparatus freely throw into theliquid sample for soaking for more than 15 minutes, to detect by thedetection apparatus. Eventually, the flow of liquid can be completedcorrectly to get effective results, indicating that the apparatus ismore casual and user-friendly while ensuring the accuracy of theresults.

The invention shown and described herein may be implemented in theabsence of any elements, limitations specifically disclosed herein. Theterms and expressions used herein are for illustration rather thanlimitation, which do not exclude any equivalents of the features andportions described herein in the use of these terms and expressions, inaddition, it should be understood that various modifications arefeasible within the scope of the present invention. It is therefore tobe understood that, although the invention has been particularlydisclosed by various embodiments and alternative features, modificationsand variations of the concepts described herein may be employed by thoseof skilled in the art, and such modifications and variations will fallinto the scope of protection of the present invention as defined by theappended claims.

The contents of the articles, patents, patent applications, and allother documents and electronic information available or documentedherein are incorporated herein by reference in their entirety, as ifeach individual publication is specifically and individually indicatedfor reference. The applicant reserves the right to incorporate any andall materials and information from any such article, patent, patentapplication or other document into this application.

What is claimed is:
 1. A detection apparatus for detecting an analyte ina liquid sample, comprising: a base layer, wherein the base layercomprises a groove for containing a test strip therein, the test stripcomprising a sample applying area and a test area, wherein the teststrip is disposed in the groove and a part of the sample applying areaof the test strip is located in a sample chamber; and a covering layer,wherein the covering layer covers the groove on the base layer to form afirst sealed channel and a second sealed channel, the first sealedchannel accommodating the test area of the test strip and the secondsealed channel forming the sample chamber, wherein the sample chamber isconfigured to retain an amount of the liquid sample sufficient for thesample applying area of the test strip to absorb the amount of theliquid sample; wherein an opening is formed in the base layer or thecover layer, and the opening is in fluid communication with the samplechamber, wherein the opening is configured to allow the amount of theliquid sample to enter into the sample chamber for contacting the sampleapplying area when the detection apparatus is inserted into the liquidsample.
 2. The detection apparatus according to claim 1, wherein thebase layer comprises a back side and a front side, the groove is locatedon the back side or front side of the base layer, and the covering layercovers the front side or back side of the base layer.
 3. The detectionapparatus according to claim 2, wherein the base layer is a rigid baselayer and the covering layer is a flexible or rigid covering layer. 4.The detection apparatus according to claim 3, wherein the base layer hasa first thickness, and the covering layer has a second thickness lessthan the first thickness.
 5. The detection apparatus according to claim1, wherein the opening is located in the base layer.
 6. The detectionapparatus according to claim 1, wherein the opening is located in thecovering layer.
 7. The detection apparatus according to claim 1, whereinthe opening corresponds to the sample applying area on the test strip,or the opening exposes a portion of the sample applying area.
 8. Thedetection apparatus according to claim 1, wherein the opening is formedby hollow adjacent areas at the bottom of the groove.
 9. The detectionapparatus according to claim 1, wherein the sample chamber is located atone end of the base layer and at the upstream of a labeled area of thetest strip, and wherein the labeled area is at the upstream of the testarea.
 10. The detection apparatus according to claim 1, wherein thedetection apparatus further comprises a structure that reduces, limitsor eliminates capillary flow and prevents liquid from flowing through acapillary gap formed between the test strip and a side wall of a cardslot.
 11. The detection apparatus according to claim 10, wherein thestructure is on the side wall of the card slot.
 12. The detectionapparatus according to claim 10, wherein the structure is a protrudingtenon structure, so as to keep a certain distance between the test stripand the side wall of the card slot, thereby reducing, limiting, oreliminating the capillary gap formed between the test strip and the sidewall of the card slot.
 13. The detection apparatus according to claim10, wherein the structure is located at the upstream of a labeled areaof the test strip, or the downstream of the test area, or the upstreamof the sample chamber.
 14. The detection apparatus according to claim13, wherein the structure is located at the upstream of a labeled area.15. The detection apparatus according to claim 1, wherein the samplechamber comprises a supporting structure that supports the sampleapplying area of the test strip so that all areas of the test strip arein a plane.
 16. The detection apparatus according to claim 15, whereinthe sample chamber comprises a bevelled area that enlarges the volume ofcollectable samples.
 17. The detection apparatus according to claim 16,wherein the bevelled area is located in the vicinity of the opening. 18.The detection apparatus according to claim 15, wherein the samplechamber comprises an area that makes the side wall of the formed samplechamber to become thin, thereby increasing the volume of collectablesamples in the area.
 19. The detection apparatus according to claim 1,wherein the groove further comprises an exhaust structure, and when theliquid sample enters a card slot, a part of a gas in the card slot isexhausted from the card slot via the exhaust structure.
 20. Thedetection apparatus according to claim 19, wherein the exhaust structureis located at the bottom of the groove.
 21. The detection apparatusaccording to claim 20, wherein the exhaust structure is a groovestructure.
 22. The detection apparatus according to claim 19, whereinone end of the exhaust structure is in communication with the groove andthe other end is in communication with outside atmosphere.
 23. Thedetection apparatus according to claim 19, wherein one end of theexhaust structure is in communication with the groove and the other endis in communication with the opening.
 24. The detection apparatusaccording to claim 1, wherein the detection apparatus further comprisesone or more liquid channels, and the one or more liquid channels are incommunication with the sample applying area of the test strip.
 25. Thedetection apparatus according to claim 24, wherein the one or moreliquid channels are disposed at the upstream of the opening.
 26. Thedetection apparatus according to claim 25, wherein the one or moreliquid channels are disposed on the sample chamber.
 27. The detectionapparatus according to claim 26, wherein the one or more liquid channelsare disposed at the bottom of the sample chamber.
 28. The detectionapparatus according to claim 24, wherein the one or more liquid channelsexpose a portion of the test strip.
 29. The detection apparatusaccording to claim 28, wherein the one or more liquid channels expose anend portion of the sample applying area of the test strip.
 30. Thedetection apparatus according to claim 24, wherein the size of the oneor more liquid channels makes the liquid sample stored in the samplechamber unable to flow out of the sample chamber through the one or moreliquid channels due to the surface tension.